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Regulatory Affairs Manager

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”                                                        

Top 3 Must Have Skills        
  • A minimun of a BS degree w/ 5 years of directly related experience (manufacturing or quality experience)
  • Must have CMC-specific regulatory knowledge & experience with product lifecycle changes impacting CTAs and MAs, including biologics and small molecules
  • Organized, able to multitask, and have a track record of completing deliverables on time with high quality
  • Excellent communication (both written and verbal), presentation and facilitation skills

Day to Day Responsibilities:    
  • Assess change controls for reportability
  • Assess manufacturing deviations for reportability
  • Gather country specific documents for submissions

"This posting is for Contingent Worker, not an FTE"

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